title: Bendamustine with or without rituximab in the treatment of relapsed chronic lymphocytic leukaemia: an Italian retrospective study.
abstract: To retrospectively assess the efficacy of bendamustine alone and with rituximab (R-B), 109 patients with relapsed chronic lymphocytic leukaemia (CLL) were enrolled in 24 Italian centres. The median age was 66 years (range 39-85). Forty-three percent of patients had relapsed and 57% were resistant (median previous therapies = 3; range 1-8). Twenty-two patients received bendamustine alone and 87 patients received R-B (median B dosage: 100 mg/m(2) per day, range 90-130 mg/m(2) per day). The overall response rate was 69·6% (complete response 28·6%; partial response 41%), and was significantly higher in patients treated with R-B (P = 0·014) and in those responsive to the previous treatment (P=0·04). After a median follow-up of 7·9 months (range 1-148), the median progression-free survival was 16 months and the median duration of response was 13 months. Median overall survival (OS) was 16·8 months for the whole cohort; patients not responding to the treatment had a significantly worse outcome than those who attained a response (P = 0·0001). In multivariate analysis, only resistant disease status at start of bendamustine treatment (HR 3·2, 95% CI 1·4-7·3, P = 0·006) had an independent prognostic value for OS. Toxicity was manageable and mostly haematological. In conclusion, in our experience R-B was an effective and well-tolerated treatment for relapsed/refractory CLL patients, producing a remarkable high CR rate and mild toxicity.
authors.affiliation: UO di Ematologia, AOUP Paolo Giaccone, Palermo, Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Iannitto
authors.forename: Fortunato
authors.initials: F
authors.lastname: Morabito
authors.forename: Salvatrice
authors.initials: S
authors.lastname: Mancuso
authors.forename: Massimo
authors.initials: M
authors.lastname: Gentile
authors.forename: Antonella
authors.initials: A
authors.lastname: Montanini
authors.forename: Accursio
authors.initials: A
authors.lastname: Augello
authors.forename: Velia
authors.initials: V
authors.lastname: Bongarzoni
authors.forename: Alfonso
authors.initials: A
authors.lastname: D'Arco
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
authors.forename: Rita
authors.initials: R
authors.lastname: Fazzi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Franco
authors.forename: Roberto
authors.initials: R
authors.lastname: Marasca
authors.forename: Antonino
authors.initials: A
authors.lastname: Mulè
authors.forename: Maurizio
authors.initials: M
authors.lastname: Musso
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Elsa
authors.initials: E
authors.lastname: Pennese
authors.forename: Andrea
authors.initials: A
authors.lastname: Piccin
authors.forename: Delia
authors.initials: D
authors.lastname: Rota-Scalabrini
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Visani
authors.forename: Luigi
authors.initials: L
authors.lastname: Rigacci
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D004341:Drug Evaluation / Q000379:methods; D019008:Drug Resistance, Neoplasm; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D009588:Nitrogen Mustard Compounds; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride